DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES

Manufacturer
Zydus Lifesciences Limited
Effective date
2025-04-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 21:28:45

Label at a glance#

Productdimethyl fumarate
Active ingredientDIMETHYL FUMARATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1532-3

30-Day Starter Pack Carton Label

Dimethyl Fumarate Delayed-release Capsules

120 mg Starter Dose: 14 Capsules

240 mg Regular Dose: 46 Capsules

Rx only

label
label

NDC 70771-1530-7

Dimethyl Fumarate Delayed-release Capsules, 120 mg

14 Capsules

Rx only

label
label

NDC 70771-1531-6

Dimethyl Fumarate Delayed-release Capsules, 240 mg

60 Capsules

Rx only

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373497{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } PackGPCK5
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN5
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN5
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSN5
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD5
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
782c9b32-f61c-48d7-9845-328403da8b33Product name520250303
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1530-7dimethyl fumarate14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
70771-1531-6dimethyl fumarate60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
70771-1531-8dimethyl fumarate46 in 1 BOTTLECAPSULE, DELAYED RELEASE465
70771-1532-3dimethyl fumarate1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1530DIMETHYL FUMARATE (DIMETHYL FUMARATE) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 1 package rows20250403_7203a262-de0f-42dd-b4fb-8856758b82e9.zip
70771-1531DIMETHYL FUMARATE (DIMETHYL FUMARATE) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20250403_7203a262-de0f-42dd-b4fb-8856758b82e9.zip
70771-1532DIMETHYL FUMARATE (DIMETHYL FUMARATE) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Legacy NDC, 1 package rows20250403_7203a262-de0f-42dd-b4fb-8856758b82e9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-153070771-1530-7
70771-153170771-1531-8, 70771-1531-6
70771-153270771-1532-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 100 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210538-001DIMETHYL FUMARATEDIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24
A210538-002DIMETHYL FUMARATEDIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24c2088c7a36db…
2026-10-15 13:18:302026-09A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24c2088c7a36db…
2026-09-14 22:38:342026-08A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2484e616aacf4f…
2026-08-18 06:07:402026-07A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210538-001DIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORAL2020-09-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210538-002DIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORAL2020-09-244b0b4de00fa7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-03-12 10:30 UTC2021-03A210538-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210538-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210538-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210538-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210538-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210538-002AB1c0c555d07b60…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dimethyl fumarateDIMETHYL FUMARATEZydus Lifesciences Limited7203a262-de0f-42dd-b4fb-8856758b82e92025-04-01Exact identifier
ndc (package): 70771-1530-7
ndc (package): 70771-1531-6
ndc (package): 70771-1531-8
ndc (package): 70771-1532-3
ndc (product): 70771-1531
ndc (product): 70771-1532
ndc (product): 70771-1530
ndc11 (package): 70771153108
ndc11 (package): 70771153007
ndc11 (package): 70771153106
ndc11 (package): 70771153203
spl id: d8dceb92-b903-4b29-b3e6-4651fbc598fe
spl set id: 7203a262-de0f-42dd-b4fb-8856758b82e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.